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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00799903 |
This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) in people with coronary heart disease.
Condition | Intervention | Phase |
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Atherosclerosis Cardiovascular Disease Coronary Heart Disease CV Risk |
Drug: Darapladib Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) |
Estimated Enrollment: | 15500 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | October 2012 |
Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Darapladib: Experimental
Single daily oral tablet
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Drug: Darapladib
Lp-PLA2 inhibitor administered in addition to standard therapy
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Placebo: Placebo Comparator
Single daily oral tablet
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Drug: Placebo
Placebo administered in addition to standard therapy
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Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. Following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, and every 6 months until the end of the study. Average time in the study for an individual subject is expected to be about 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 100601 |
Study First Received: | November 26, 2008 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00799903 |
Health Authority: | Hungary: Országos Gyógyszerészeti Intézet; Italy: Ethics Committee; Pakistan: Drug Controller R&D Ministry of Health; Peru: Institutional Review Board; Philippines: Bureau of Food and Drugs; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: National Medicines Agency; Czech Republic: State Institute for Drug Control; Czech Republic: Státní ústav pro kontrolu léčiv, Oddělení klinického hodnocení; Denmark: Lægemiddelstyrelsen; Estonia: The State Agency of Medicine; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Argentina: Ministry of Health; Belgium: Federal Agency for Medicinal Products and Health Products; Brazil: Institutional Review Board; Bulgaria: Bulgarian Drug Agency; Canada: Health Canada; Chile: Institutional Review Board; China: State Food and Drug Administration; South Africa: Medicines Control Council; South Korea: Korea Food and Drug Administration (KFDA); Spain: Spanish Agency of Medicines; Sweden: Läkemedelsverket; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Norway: Statens Legemiddelverk |
Atherosclerosis coronary heart disease cardiovascular disease heart disease Lp-PLA2 inhibitor |
Arterial Occlusive Diseases Coronary Disease Atherosclerosis Heart Diseases Myocardial Ischemia |
Vascular Diseases Ischemia Arteriosclerosis Coronary Artery Disease |
Cardiovascular Diseases |